EMA
European Medicines Agency
The EU regulator for centrally-authorised medicines. Publishes shortage notifications, DHPC safety letters, and the master catalogue of all centrally-approved products.
❓ Frequently asked questions
▸ What does the EMA regulate?
Centrally-authorised medicines — products approved for the entire EU in a single procedure (mostly innovative therapies, biologics, oncology, orphan drugs).
▸ Does the EMA replace national medicine agencies?
No. National agencies (BfArM, ANSM, AEMPS, etc.) still regulate medicines authorised at country level. EMA handles the EU-wide centralised path.
▸ Where do EMA shortage notifications come from?
Marketing authorisation holders are legally required to notify EMA at least 2 months before an anticipated supply problem starts.